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FDA 510(k), K112556, ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS
FDA 510(k), K112556, ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS
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510(K) Number: K112556
Device Name: ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS
Manufacturer: VALERIE GIAMBANCO
Device Classification Name: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Regulation Number: MEH
Classification Product Code: KXA
Date Received: 09/02/2011
Decision Date: 09/28/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS
Manufacturer: VALERIE GIAMBANCO
Device Classification Name: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Regulation Number: MEH
Classification Product Code: KXA
Date Received: 09/02/2011
Decision Date: 09/28/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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